May 05 2009

More China Stem Cell Quackery

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One of my earliest blog posts in NeuroLogica was exposing clinics in China that are offering stem-cell therapy for a range of neurological disorders. The post focused on Dr. Hongyun Huang and his clinic, but there are, unfortunately, many others. A new Chinese stem cell clinic, Beike Biotechnologies, has been in the news recently, showing that the practice, if anything, is growing in China.

The use of stem cells to treat neurological injury or degenerative disease is certainly a promising idea. In 10-20 years such treatments may not only be a reality, they may revolutionize our approach to some diseases. But there is a long lead up of scientific research before a new biomedical technology becomes a reality – if it ever does. This often means that there is a long period of media hype preceding scientific reality. This has been especially true for stem cells, likely resulting from the ethical controversy and partial Bush Administration ban on stem cell research.

There are a number of clinics and companies around the world, but especially in China, taking advantage of this premature media hype, and the desperation of people with serious injury. They are offering stem cell treatments now, and claiming stunning rates of cures. At the same time they are offering zero scientific evidence to back up their claims. That is a formula well known to those of use who pay attention to health fraud – stunning claims combined with a lack of rigorous scientific evidence = fraud. At least that is a reasonable default assumption until the evidence is presented.

In fact, the greater the treatment effect being claimed the easier it would be to document scientifically. Large treatment effects and high rates of success can be documented relatively easily with relatively few subjects. So why haven’t they done so? They have no legitimate excuse. In fact, if their treatments worked as claimed they would be doing the world a huge disservice by failing to document it in a way that would convince the scientific and medical world. They are depriving millions of patients effective treatment.

Dr, Sean Hu from Beike Biotechnology was recently interviewed by Karolyn Y. Zeng for H+ magazine. The interview, in my opinion, is absolutely terrible from a journalistic point of view. Her questions are obvious and she never asks the hard questions – where is the scientific evidence, and why are your claims not generally accepted. The result was little more than an advertisement for Hu’s clinic. In the interview Dr. Hu claims:

As of February 2009, Beike has treated over 5,087 patients with cord blood stem cell injections for diseases like ataxia, autism, ALS, brain trauma, cerebral infarction, cerebral hemorrhage, cerebral palsy, diabetics, Guillain-Barre, encephalatropy, and spinal cord injury – many of these are considered incurable diseases.

(I think “encephalatropy” is supposed to be encephalopathy.)  Here we see another red flag for quackery – the claim that a host of different conditions can be treated with a single therapy. These conditions involve the brain, the spinal cord, and the peripheral nerves – all with distinct cell types and characteristics that would likely not be treated by the same type of stem cells. Autism is also a very different kind of disorder from the other entities as there is no cell damage that we know of. Although the exact nature of autism remains unknown, it appears to be the result of differences in brain organization and communication – not cell damage.

What Dr. Hu offers instead of scientific evience is yet another red flag for quackery – anecdotes. He even encourages his patients to keep a blog of their experience at the clinic. As I have discussed numerous times before, anecdotes are highly misleading and are not a way to discern whether or not a treatment works. Here is one story being reported on a spinal cord injury blog, regarding one patient with ataxia:

“Immediately, I was about 20 per cent better,” he says.

Since returning to Canada in February, he’s had a relapse of symptoms. But he says that was probable considering the degenerative nature of ataxia. He’s now looking at other stem-cell treatments.

Stem cells do not work “immediately” even if they do work.  So any report of immediate recovery is suspect, and is likely either due to the placebo effect or to a temporary response to anesthesia or some other aspect of the treatment. Of course, this temporary effect quickly faded leading to the “relapse”, which the patient rationalized as a result of the degenerative nature of his condition. However, it is easier explained as a simple treatment failure.

The placebo effect is likely to be particularly large in this situation as well. Patients spend 20+ thousand dollars for the treatment, more if you include travel expenses. Twenty percent, according to Hu, get follow up treatments at the same price.  This is often against the advice of their doctors back home who are appropriately skeptical. This creates a huge psychological need to justify the decision and the expense. I have personally seen this in my own patients who have gone for controversial treatments. Even with no objective improvement in exam or function, they will find something to justify their decision. It is often a sad display of the human potential for self-deception.

Hu claims that his company, and China in general, is just way ahead of the western medical establishment.  This is simply not credible. No one is that far ahead – there simply has not been enough time. It is true that research was slowed in the US by the Bush ban, but not by that much. And research continued in Korea, Japan and Europe as well.

The simple fact is that the technology is not yet at the point where there are proven effective treatments – let alone for a long list of the hardest neurological disorders to treat. Researchers are still working out the basic science and technology – making stem cells from various sources, investigating their properties, learning how to use them, to get them to do what we want without causing cancer or other unwanted side effects.

At best we are at the point where early clinical trials are possible for a limited number of the easiest conditions to treat. So Hu and these other Chinese clinics are claiming they are not just ahead of the rest of the world, but by one to two decades.  And they have nothing to show for it in the way of scientific evidence. They may or may not be sincere in their claims, but that does not matter. This is unacceptable behavior.

It is also a financial boon for these clinics – they can charge 20 thousand dollars per treatment, and rich desperate westerners are glad to give it to them. Desperate patients are also in no position to do anything about it if the treatments fail. They are given no guarantees. The treatments are experimental, and they know they are taking a chance. If they are harmed they have no recourse. The situation is ripe for exploitation.

It is also very difficult to dissuade patients from seeking such treatments.  The possibility of hope, no matter how tenuous, is simply too much of a lure. When journalists or bloggers try to do a “balanced” treatment of the topic they typically include scientific skepticism and anecdotes of sucess. Of course most patients will find the anecdotes more compelling. And much of the journalism, like the Zeng interview, is not balanced and ends up being gushing and promotional.

At present all we can do is educate patients about the situation and give our advice and hope they make the right decision.  We could also put pressure on the Chinese government to better regulate these clinics, but that seems unlikely. Also, there are similar clinics in many countries, not just China. This is one of those unintended consequences of globalization – fraudulent clinics can be set up outside of regulatory jurisdiction, and then clients can be lured there through advertising and gullible journalism on the internet.

While hopes for stem cell therapy remain legitimately large, we are not there yet. Any treatment currently being offered should be in the context of a properly designed clinical trial, with informed consent and ethical oversight. Any clinic selling stem cell therapies for thousands of dollars is therefore likely to be a cruel fraud.

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